Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients

NCT04040478 | Completed

• 1 other identifier: TCM study
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate if non-invasive continuous transcutaneous blood gas monitoring can detect tissue perfusion and hypoxemia and the relation to other circulatory parameters such as pulse, blood pressure, cardiac output and arterial saturation.

Conditions

Transcutaneous Monitoring; Microcirculation; Peripheral Perfusion; Tissue Metabolism

Outcome Measures

Primary Outcomes (2)

• Changes in tcpO2 and tcpCO2 compared to changes in cardiac output, perfusion index and arterial paO2 and paCO2

  Percentage changes in tcpO2 and tcpCO2 compared to percentage changes in cardiac output, perfusion index and arterial blood gas analysis of paO2 and paCO2

  6 hours

• Changes in tcpO2 and tcpCO2 before, during and after the arterial clamping during the surgery.

  Changes in tcpO2 and tcpCO2 before arterial clamping vs after arterial clamping in the leg undergoing surgery

  6 hours

Study Arms (2)

Abdominal

80 patients undergoing surgery for abdominal cancer. Data review for interim analysis will be conducted after the participation of 40 patients to evaluate the requirement for further enrollment.

Device: Transcutaneous monitoring

Vascular

20 patients undergoing femoral endarterectomy.

Device: Transcutaneous monitoring

Interventions

Transcutaneous monitoring DEVICE

Transcutaneous monitoring of oxygen and carbon dioxide by using Radiometer TCM5 flex monitor with 3 electrodes on the patient. Abdominal patients are monitored for 4 hours during surgery and for 2 hours in the Post-Anesthesia Care Unit. Arterial blood gasses are drawn from the arterial line 4 times during surgery and 4 times after surgery. Patients undergoing vascular surgery are monitored for up to 4 hours during surgery.

Abdominal; Vascular

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Rigshospitalet due to surgery for abdominal cancer (Whipple procedure) and vascular surgery (femoral endarterectomy)

You may qualify if:

• patients undergoing surgery for abdominal cancer
• patients undergoing femoral endarterectomy

You may not qualify if:

• patients not able to give a informed consent

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Radiometer Medical ApS: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Sigvardt E, Rasmussen SM, Eiberg JP, Sorensen HBD, Meyhoff CS, Aasvang EK. Transcutaneous blood gas monitoring and tissue perfusion during common femoral thromboendarterectomy. Scand J Clin Lab Invest. 2022 Jul;82(4):334-340. doi: 10.1080/00365513.2022.2092900. Epub 2022 Jun 29.

  PMID: 35767233 DERIVED

MeSH Terms

Interventions

Blood Gas Monitoring, Transcutaneous

Intervention Hierarchy (Ancestors)

Oximetry; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Eske Aasvang, MD phD DMSci

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of research, Principal investigator, ass. professor

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: June 15, 2019
• Primary Completion: December 31, 2019
• Study Completion: April 1, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

DK (1)